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Subject:
From:
"Valerie W, McClain" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 8 Jun 2004 05:38:05 EDT
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Naomi,
My understanding of the changes in the FDA GRAS policy is limited.  There is
a document that would give you the history of the rule change in the FDA--its
56 pages long.  But it might be helpful to you.
http://vm.cfsan.fda.gov/~lrd/fr970417.html

I think it is important to realize that GRAS is no longer an affirmation
process but a notification procedure.  Companies are notifying the FDA that they
believe their product is GRAS, and the FDA is accepting their determination.
Read GRAS notices and carefully read the wording.  The GRAS notification on
Martek's DHA and AA states that they accept Martek's determination that their
microbial oils are GRAS.  It does not say that the FDA has determined that the
oils are GRAS.

You might want to read a most interesting document that was published in
Accountability in Research (1999) Vol 6, pp 259-310 called "The Toxicity/Safety of
Processed Free Glutamic Acid (MSG):  A Study in Suppression of Information"
by Adrienne Samuels.
http://www.truthinlabeling.com/l-manuscript.htm

There are a number of people (myself included) and organizations that believe
that the FDA is very much influenced by industry.
Valerie W. McClain, IBCLC

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